FDA Approves Sklice Lotion

The U.S. Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion treats lice in most patients with a single 10-minute application of the lotion, without nit combing.

Sklice Lotion contains a broad-spectrum antiparasitic agent, ivermectin, which was developed from a soil bacterium that produces a family of compounds (avermectins) shown to bind selectively and with high affinity to certain ion channels present in invertebrate nerve and muscle cells but not in mammals. The resulting increased permeability of the cell membrane causes paralysis and death in certain parasites.

Widespread oral use of ivermectin began in 1987 to control river blindness (onchocerciasis) in humans. More than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by river blindness and other parasitic conditions.

Sklice Lotion Patient Information

Important: For use on scalp hair and scalp only. Do not use ivermectin lotion in your eyes, mouth or vagina. Read the Patient Information that comes with Sklice Lotion. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

General information about Sklice Lotion

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this lotion for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about Sklice Lotion. If you would like more information, talk to your healthcare provider. You can also ask your healthcare provider or pharmacist for information about Sklice Lotion that is written for health professionals.

Instructions for Use

Before you use Sklice Lotion, it is important that you read the Patient Information and the Instructions for Use. Be sure that you read, understand, and follow the Instructions for Use so that you use Sklice Lotion the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Sklice Lotion.

Your hair and scalp must be dry before application.

Use the top of cap to break the tamper seal on the tube.

Apply lotion directly to dry hair and scalp.

Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair.

Rub Sklice Lotion throughout your hair.

It is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.

Use up to 1 entire tube (4 oz) to completely cover hair and scalp.

Allow it to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with the lotion.

After 10 minutes, completely rinse the lotion from your hair and scalp using only water.

You or anyone who helps you apply Sklice Lotion should wash their hands after application.

Do not use again without talking to your healthcare provider first.

How do I stop the spread of lice?

To help prevent the spread of lice from one person to another, here are some steps you can take:

Avoid direct head-to-head contact with anyone known to have live, crawling lice.